Press Releases

EydisBio, Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to EYD-001, its highly selective and potent, orally bioavailable TAK1 inhibitor for the treatment of systemic sclerosis. EydisBio is an early-stage pharmaceutical company leveraging a novel approach to treating various autoimmune and inflammatory diseases, including rare diseases. For more information about the Company, their developmental programs and pioneerin

Wheeler Bio, Inc., an agile contract development and manufacturing organization (CDMO), announced today an expansion in capabilities through the licensing of ATUM’s innovative miFuc™ platform designed for expression of recombinant proteins containing afucosylated glycans. ATUM’s miFuc™ technology is the industry-leading platform for the development of antibodies with significant reduction in fucosylation without affecting product titer, cellular growth rates,

Capricor Therapeutics a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, announced today, following recent meetings with the U.S. Food and Drug Administration (FDA), its intent to file a Biologics License Application (BLA) based on existing cardiac and natural history data for deramiocel to treat all patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy. Following the FDA meetings:

AstraZeneca’s Fasenra (benralizumab) has been recommended for approval in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal.1,2 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results

Teva Pharmaceutical Industries Ltd. announced today that a new analysis from the European cohort of the RIM-TD open-label extension (OLE) study revealed that deutetrabenazine treatment of patients with Tardive Dyskinesia (TD) was associated with long term improvement of TD symptoms. The improvement in symptoms was sustained throughout the three-year study, and deutetrabenazine was well tolerated.1 The data were presented at the European College of Neuropsychopharmacology (ECNP) annual congres

Thrombolytic Science, LLC (TSI), a private clinical-stage biotech company focused on developing clot-dissolving therapies for thrombotic diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for mutant prourokinase, a recombinant fibrinolytic pro-enzyme. A U.S.-based clinical trial will further confirm the safety and tolerability of TSI's novel mutant prourokinase (mproUK) in healthy volunteers. &ldq

AbbVie today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of mirvetuximab soravtansine (ELAHERE®) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant and high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior treatment regimens. Patie

AstraZeneca’s Fasenra (benralizumab) has been recommended for approval in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal.1,2 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results

Johnson & Johnson announced that its subsidiary, Red River Talc LLC (“Red River”), filed a voluntary prepackaged Chapter 11 bankruptcy case today in the U.S. Bankruptcy Court for the Southern District of Texas (the “Bankruptcy Court”) to fully and finally resolve all current and future claims related to ovarian cancer arising from cosmetic talc litigation against the Company and its affiliates in the United States. Red River filed the bankruptcy case

Today, the U.S. Food and Drug Administration approved FluMist for self- or caregiver-administration. FluMist is approved for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age. FluMist is sprayed into the nose and has been used safely and effectively for many years. It was initially approved by the FDA in 2003 for use in individuals 5 through 49 years of age, and in 2007, the FDA approved the use of FluMist to include childr